The Food and Drug Administration has identified a Class I recall of Abiomed Automated Impella Controllers due to the potential for serious injury or death. The FDA said Abiomed found cybersecurity vulnerabilities related to network and physical access that could be compromised and result in the product being exploited by a loss of control or having an unexpected pump stop. To date, no cyberattacks or incidents of patient harm due to the vulnerabilities have been reported. The FDA said the recall involves correcting the devices and not removing them from where they are used or sold.
This recall involves correcting devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
| Product Code(s) | Product Description(s) | UDI-DI(s) | Impacted Serial Numbers |
|---|---|---|---|
| 0042-0000-US | Impella Controller, Packaged, US | 00813502010022 | All |
| 0042-0010-US | Impella Optical controller, Packaged, US | 00813502010985 | All |
| 0042-0040-US | Optical, AIC, Impella Connect, Pkgd, US | 00813502011401 | All |
| 1000432 | AIC w/Impella Connect for ECP | 00813502013030 | All |
| 1000201 | Dbl Optical, AIC Impella Connect, Pkg US | 00813502010442 | All |
Read the full recall details here.
